A Clinical research administrator is responsible for the overall management of a clinical research study. They ensure that the study is conducted in accordance with Good Clinical Practice (GCP) and all regulatory requirements.
Where can you work?
Clinical Research Administrators can work in any of the following settings:
- Pharmaceutical Companies
- Contract Research Organizations (CRO)
- Academic Medical Centers or Teaching Hospitals
What will you do as a clinical research administrator?
As a Clinical research administrator, you would be responsible for but not limited to:
- Overseeing the study budget and managing financial resources: This includes ensuring proper use of the study budget, monitoring costs to spot cost overruns, and estimated savings.
- Monitoring each aspect of the study: This includes reviewing all non-financial documents and data on a regular basis (daily, weekly or monthly) to ensure that they comply with regulatory requirements and GCP guidelines.
- Recruiting sites: This involves finding qualified clinical research sites where you would manage contracts and monitor on an ongoing basis on site performance.
- Ensuring that all investigational product (IP) is properly signed out as well as ensuring documentation for IP shipments is complete before leaving your company's premises.
- Monitoring patient recruitment: You will be responsible for ensuring that the number of patients recruited meets or exceeds agreed-upon objectives.
- Monitoring patient safety: This would include ensuring that patient safety is always protected. You may be responsible for some audits or inspections of study sites, along with reporting any violations to the appropriate authority (e.g., FDA).
- Managing contract services: As Clinical Research Administrator, you will manage all clinical research support staff and services required to successfully complete the clinical trial.
- Developing study protocols and timelines: This includes ensuring that the study protocol is written in accordance with GCP guidelines and all regulatory requirements.
- Collecting and analyzing data: This includes ensuring that the statistical analysis plan is followed, reviewing generated data for quality and completeness. You would write reports summarizing study results for regulatory authorities and other decision-makers within your organization.
What should you know before becoming a clinical research administrator?
You should possess excellent written and oral communication skills as you will be required to work with all members of the clinical research team (e.g., sponsors, investigators, statisticians), regulatory organizations (e.g., FDA) as well as others within your company (e.g., Marketing).
You should also be willing to travel (25%-50% travel may be expected; it depends on the industry). As this position requires interaction with people from different levels in an organization, you should possess superior leadership and interpersonal skills.
As this position requires you to manage budgets, you should also have excellent financial management skills (e.g., prepare budgets, monitor expenses).
What does a typical day look like?
The main responsibility of clinical research administrators is to monitor the progress of all ongoing clinical trials. They are in charge of ensuring that these studies follow all standard operating procedures (SOP) or good clinical practice (GCP), which includes protecting the rights, safety, and welfare of study participants.
This role can be challenging because it requires extensive knowledge in many areas, such as pharmaceutical regulations, ICH-GCP E6(R2), protocol writing, and Good Clinical Laboratory Practice (GCLP). As a clinical research administrator, you may perform some or all of the following tasks:
- Review study documents such as the clinical investigation plan, clinical study report, and statistical analysis plan.
- Oversee the conduct of the study by reviewing data and source documents for accuracy.
- Ensure that sites are performing in accordance with the protocol.
- Ensure that patient enrollment is on track.
- Coordinate contract services and monitor their performance.
- Review data for quality and completeness.
- Write reports summarizing study results.
The work of a clinical research administrator is never done! In order to ensure that all studies are conducted in a safe, efficient, and timely manner, these administrators must be on their toes at all times. They often work long hours, especially during the final stages of a study when everything needs to be checked.
Necessary and extra skills
- Active listening: to understand the study protocol and other studies staff instructions
- Critical thinking: to identify potential issues with the study and develop corrective action plans
- Decision making: to independently make critical decisions in a timely manner that adhere to clinical research standards
- Problem-solving: to troubleshoot clinical research operational or regulatory problems
- Time management: to ensure that all aspects of the clinical trial are completed on schedule
- Reading comprehension: to read clinical research protocol or other study documents
- Analytical skills: to review, understand and manage the study budget
- Communication skills: oral communication with internal audiences (e.g., team members) and external authorities (FDA, etc.)
- Negotiation skills: to interact with all parties involved in the drug development process including physicians, investigators, or industry partners
- Coordination: of all study activities and staff to support the clinical development process
- Flexibility: to adapt to rapidly changing situations and priority management
- Facilitation of meetings: preparing for and conducting meetings with internal and external stakeholders. Including organizing, planning, recording the minutes.
- Technical writing: writing protocols, SOPs, or other study documents
Do you need special experience?
Minimum of 3 years of experience in the pharmaceutical/CRO industry, with at least 2 years in a clinical research role. Alternatively, an equivalent number of years in another relevant healthcare field (e.g., nursing, pharmacy).
What are the education requirements?
A bachelor's degree in a scientific field is the typical educational requirement for a Clinical research administrator however many employers may prefer or require a Master's degree. Experience in the pharmaceutical or clinical research industry is also beneficial.
It is also common for employers to require at least five years of experience in GCP studies management and/or medical writing in addition to formal training on Good Clinical Practice (GCP) standards. Training on GCP is available through a variety of resources, including online courses, workshops, and conferences.
How much does a clinical research administrator make?
This salary will vary depending on who you work for; it can range from $60K to $100K per year. Large pharmaceutical companies pay their clinical research administrators very well as they require proven expertise in managing studies. Working for large pharmaceutical companies also means that there is no shortage of career opportunities.
Contract Research Organizations generally provide lower salaries than Pharmaceutical Companies but this may be balanced by less stress and more flexible working hours.
How to apply for a clinical research administrator position?
A number of resources are available to help you understand what you need to know before applying for a clinical research administrator position. For example, the FDA provides information about requirements specific to clinical trial sponsors.
The Clinical Research Leadership Associates also has numerous resources available for download on their website. The Information Management Services Group (IMS) has an updated list of webinars that may be helpful in your job search as well, including "Developing Your GCP Compliance Plan" and "For-Profit vs. Nonprofit Organization GCP Compliance Plans".
Professional organizations, such as the Association of Clinical Research Professionals or the American Society of Clinical Oncology often have job postings on their websites.
When you are ready to apply for a position, review the job description carefully to make sure you have the skills and experience required. Format your resume to highlight your experience in clinical research and include examples that demonstrate your ability to successfully manage clinical trials. Finally, be prepared to answer questions about your experience and knowledge of GCP during an interview.
How to pass the interview successfully?
The Association of Clinical Research Professionals (ACRP) offers some tips on how to prepare for an interview, including reviewing the job description thoroughly and coming up with specific examples that demonstrate your skills and experience. It is also important to be familiar with the company's mission and vision.
In addition, practice answering common interview questions such as "What drew you to clinical research?" or "What are some of the challenges you have encountered in your previous roles?"
Be prepared to talk about your knowledge of GCP and how you stay up-to-date on current regulatory changes. Finally, always show enthusiasm for the role and be prepared to ask questions about the company and the position.
What skills should you emphasize in your resume of a clinical research administrator?
When writing your resume, be sure to focus on the skills that are relevant to a clinical research administrator position. Some key skills to highlight include:
- Project management: organizing and coordinating multiple tasks simultaneously, setting deadlines, and managing budgets
- Leadership: motivating and directing team members, providing support and guidance
- Critical thinking and problem-solving: ability to identify issues and develop solutions
- Technical writing: writing protocols, SOPs, or other study documents
- Computer skills: Microsoft Office Suite, databases, clinical research software applications
- Organizational skills: time management, attention to detail, multitasking abilities
- People skills: communication (verbal and written), diplomacy, customer service orientation
The Clinical Research Leadership Associates also has a detailed list of skills that are essential for a successful career in clinical research.
What certifications are available?
There are several certificate programs that may help you improve your skills and knowledge related to this job. For example, The Clinical Research Associate Certificate Program will provide participants with the necessary knowledge and practical skills to work as clinical research associates.
The program is led by experienced industry professionals who will share their expertise on various topics including good clinical practice (GCP), ICH-GCP E6, Product Development Protocols, Regulatory Compliance, Computerized Systems for Clinical Research, Data Management and Analysis… has been approved by the International Association of Clinical Research Professionals (IACRP) for 30 Continuing Education Units (CEUs).
The Pharmaceutical Industry Certificate Program offered by the University of Toronto School of Continuing Studies is designed for individuals with experience in the pharmaceutical industry who wish to develop their skills and knowledge in specific areas. The program covers a range of topics, including drug development, regulatory affairs, quality assurance, clinical research, marketing, and business strategy.
Both programs are available online and provide students with the opportunity to learn from experts in the field and network with other professionals. Clinical research administrators may also be interested in obtaining certification from professional organizations such as the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA). obtaining certification from professional organizations such as the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA).
Finally, clinical research administrators may consider enrolling in a certificate program or participating in an internship to gain experience and knowledge in the field. For example, they could complete a Clinical Research Management Training Program offered by the International Foundation for Online Responsibility (IFFOR).
The eight-week online course lets students learn from experts with extensive industry experience. Students also have access to a peer mentor program, interactive educational sessions, and interactive simulations designed to immerse trainees into the real world of clinical research administration.
Career paths for clinical research administrator
Once they have completed their training and gained experience in the field, clinical research administrators may consider pursuing positions at pharmaceutical and biotechnology companies, medical and surgical hospitals, and community clinics. They could also work as services vendors for clients such as physicians' offices and insurance companies. Also, clinical research administrators may also pursue leadership roles such as Clinical Research Directors and Vice Presidents.
In addition to jobs in the pharmaceutical industry, clinical research administrators may also work for other companies that offer products and services to the health care sector. For example, they could find employment at biotechnology or medical equipment firms, government agencies, or consulting groups working on clinical studies.
What is the employment outlook for this career?
According to the US Bureau of Labor Statistics, jobs for medical and health services managers are expected to grow by 25 percent between the last 5 years (faster than average). This means that there will be approximately 459,300 new jobs in that period of time. There will also continue to be a need for experienced clinical research professionals who can work effectively with researchers, study coordinators, and other members of an interdisciplinary team.
In general, clinical research administrators enjoy their job because they have an opportunity to use their skills and knowledge in a unique field. In this role, they deal with several stakeholders on a regular basis including management, staff members, and clients. They also learn more about the pharmaceutical industry's operations from start to finish by managing clinical trials.
As a clinical research administrator, you will be in charge of the daily activities that take place during a clinical trial. You will manage all members of your team and contribute to the smooth flow of operations for this study.
You may also have to travel on occasion depending on where your studies are taking place.
You should enjoy working with others who are also passionate about what they do. Also, you should not mind working long hours or weekends if needed. There can be many deadlines involved with your work so it is important that you meet them accordingly. The job market for medical professionals continues to grow at an exceptional rate which creates more opportunities for people interested in becoming clinical research administrators.
Career Prospects Career options are plentiful as jobs are expected to grow at an exceptional rate in the next five years. Businesses are looking to invest in research and development so there will be a need for qualified candidates working as clinical research administrators. The growing rates of cancer, obesity, and diabetes worldwide also explain the continuous growth of the industry.